PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— PRECISE - ECLS  

Official title:

PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444764
• Other study ID #: 21-604
• Status: Recruiting
• Start date: September 16, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2023
• Source: UMC Utrecht
• Contact: Lara CA Pladet, MSc
• Phone: +31615466210
• Email: c.l.a.pladet[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Extracorporeal life support (ECLS) is used as a last resort intervention in patients with severe cardiac, circulatory and/or respiratory failure with high (>80%) expected mortality. Despite considerable improvements in patient selection and outcomes, mortality and morbidity after ECLS remain high. An improved selection and management of patients who are supported with ECLS is therefore unquestionably needed from a perspective of optimal patient care and the socio-economic impact of this costly intervention.

Description:

This observational multicenter study was designed to serve the following objectives:

1. Develop a (dynamic) prediction tool for survival and quality of life outcomes 1 year after ECLS support for the situation at baseline and 7 days after ECLS initiation

2. Study the association between application of left ventricular unloading and ECLS support duration and weanability

3. Description of the incidence of VA ECLS weaning failure and identification of predictors for VA ECLS weaning failure

Under this umbrella research protocol, the data collected by this observational multicenter study can also be reused for potential novel substudies with the objective to improve the quality of care and the efficiency of current treatment strategies involving ECLS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having received (VA and/or VV) ECLS

• All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)

• Surgical and medical patients

Exclusion Criteria:

• < 18 years of age

• ECLS confined to cardiac surgery in the operating room (OR) or in the catheterization laboratory

• Objection against use of clinical data (opt-out principle)

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation
• Extracorporeal Membrane Oxygenation Complication

Locations

Country	Name	City	State
Netherlands	Catharinaziekenhuis Eindhoven	Eindhoven	Noord-Brabant
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Netherlands	Antoniusziekenhuis Nieuwegein	Nieuwegein	Utrecht
Netherlands	Erasmus Medisch Centrum	Rotterdam	Zuid-Holland
Netherlands	UMC Utrecht	Utrecht
Netherlands	Isala Hospital	Zwolle	Overijssel

Sponsors (6)

Lead Sponsor	Collaborator
UMC Utrecht	Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, Isala, Leiden University Medical Center, St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL	By the EuroQol EQ-5D, an instrument to measure health related quality of life. It assesses health in five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression, ranging from 1 to 3 in each domain (e.g. from 1 'I am not anxious or depressed' to 3 'I am extremely anxious or depressed' in the anxiety/depression domain) finding 243 unique health states. These health states can be converted into an index ranging from 0 (death) to 1 (perfect health)	1 year after admission
Primary	Mortality		In-hospital mortality up to 30 days and through study completion, an average of 1 year.
Primary	Weaning success	30 day survival without left ventricular assist device, heart transplantation or short Term mechanical support	In-hospital up to 30 days
Secondary	Complications	Incidence of complications (infection, thrombosis, bleeding, respiratory and cardiovascular complications, mechanical complications, neurological complications)	During ECLS support up to 30 days and 1 year
Secondary	ECLS support duration	Total duration (in days) of ECLS support	ECLS days up to 30 days and 1 year
Secondary	ICU admission length of stay	Length of stay (in days) of ICU admission	ICU days up to 30 days and 1 year
Secondary	30 day mortality		30 days
Secondary	60 day mortality		60 days